2020 Legislative Recap

Over the past few months, “unprecedented” has become an oft-used term. Though the outbreak of infectious disease has been seen throughout history, the COVID-19 pandemic halted nearly all aspects of normal life, sparing not even the 2020 Regular Session of the Alabama Legislature.

When it was all said and done, only a handful of bills were passed by each Chamber, with most left hanging in the balance. However, that’s not to say the 2020 Session was without action on important health-related items; in fact; negotiations persisted well through the shutdown.

Had the Medical Association not been “on call” during these times, the health and welfare of physicians, patients and practices could have been in jeopardy.

COVID-19 Related Items

If no one was on call . . . physicians, their staff, and their practices could have no protection from COVID-19 frivolous lawsuits. The Association worked with both Sen. Arthur Orr (R-Decatur) on legislation (SB330) as well as the Ivey Administration on an executive order along with other health and business organizations. While time ran out on the legislation during the 2020 Session, the efforts with the Governor’s office were successful and on May 8, Gov. Ivey issued an executive order providing liability protection to physicians for care whose provision to patients was negatively affected or impacted by COVID-19 and/or the state’s response to the pandemic. A summary of the executive order is available here. Despite the issuance of this order, however, the Association will continue advocating for passage of Sen. Orr’s legislation, whether in a subsequent special session in 2020 or later.

If no one was on call . . . executive orders could have been issued giving out-of-state telehealth corporations unfair business advantages over Alabama medical practices. Instead, out-of-state physicians providing telehealth to Alabama patients didn’t get special treatment and had to follow the same rules as physicians living, working, and paying taxes in Alabama.

If no one was on call . . . executive orders could have been issued allowing the far-reaching, unnecessary, and dangerous scope of practice expansions. When the pandemic hit, a countrywide effort ensued from national non-physician associations seeking to advance their own specific scope-expansion agendas. These groups urged their state-level counterpart organizations to push governors to broadly expand scopes of practice in response to COVID-19, but despite this, the Ivey Administration wisely maintained physician-led, team-based care as the standard for Alabama.

If no one was on call . . . parity in payments for telehealth services may not have occurred. Parity in reimbursements for the same care provided in-person and via telehealth (especially telephonically) has long been an advocacy priority for the Association. The Association applauded the Blue Cross Blue Shield of Alabama decision to temporarily cover telephonic services by physicians beginning mid-March. Alabama Medicaid followed suit, and finally, after weeks of the Association and other allied groups petitioning Congress and Medicare regarding coverage for telephonic-only visits for seniors, CMS also agreed to cover telephonic-only telehealth. Moving forward, the Association supports making permanent these improvements in coverage of telehealth services If insurers do so voluntarily, legislation may not be ultimately necessary.

Moving Medicine Forward in 2020

For many organizations, major policy proposals and legislative initiatives fell by the wayside during the 2020 Session. However, the Medical Association saw the achievement of two top-priority funding requests (MMRC and BMSA) that were put into place in this session.

If no one was on call . . . the Maternal Mortality Review Committee (MMRC) could not have received vital funding. The Association spearheaded a coalition of stakeholders – which included March of Dimes, the American College of Obstetricians and Gynecologists, the American Academy of Pediatrics, and Johnson & Johnson – to bring awareness to the issue of increasing maternal mortality rates in Alabama and spotlight the impact this committee could have to reverse that trend if properly staffed and resourced. Gov. Ivey included funding for the MMRC in her initial budget request, and legislators maintained the funding in the final budget.

If no one was on call . . . the Board of Medical Scholarship Awards could not have received a significant funding increase. The Association worked with BMSA and the Alabama Academy of Family Physicians (AAFP) to explain how additional funding would expand the impact of this already highly successful program which awards scholarships to physicians and in turn they agree to practice in an underserved area. Gov. Ivey agreed, and the final budget included a $500,000 increase for the BMSA.

If no one was on call . . . support could not have grown for improving the existing rural physician tax credit. SB195, supported by the Association, would have amended the out-of-date definition of “rural” and strengthened the current residency requirement. The bill was passed by the Senate Committee, but died as a result of the session being cut short. This tax credit is a significant tool for attracting and retaining physicians for rural Alabama communities.

If no one was on call . . . support for strengthening Alabama’s athletic trainer statute as it relates to physician supervision and care continuity could not have grown. Prior to the session, the Association worked closely with the Athletic Trainers Association in drafting SB93 to better define the practice of athletic training, ensure appropriate physician supervision and allow joint-promulgation of athletic trainer rules. The bill passed the Senate but stalled in the House due to the shortened session.

Scope Creep – Replacing Education with Legislation

Many people would like to be a physician, but few are willing to endure medical school, residency, and all the other various education and training requirements to become an M.D. or D.O. Instead of pursuing higher education, non-physicians are pursuing legislative changes as an end-around-means to practice medicine. The Association opposes any scope of practice expansions that could endanger quality care for patients.

If no one was on call . . .the physician referral requirement for physical therapy could have been abolished. As introduced, SB104 & HB145 would have abolished the need for a medical diagnosis before a physical therapist could begin providing therapy to a patient. After consultation with many of our specialties most-involved with issuing PT referrals, the Association led negotiations to firmly maintain the importance of medical diagnosis but to also: (1) extend the current timeframe for which a referral is good from 90 to 120 days; (2) allow therapy without a referral for patients with a diagnosed chronic condition for which therapy is appropriate and who is under physician management for the condition; and, (3) allow therapy for without referral for restorative exercises so long as the patient does not initially present with new on-set pain, illness, or injury. The bill did not pass but will return.

If no one was on call . . .standards for true collaboration within practice agreements could have been abolished. While SB114 originally would have allowed an “unlimited” number of nurse practitioners a physician could supervise, the Association, understanding that one-size-doesn’t fit all when it comes to practicing medicine, negotiated a more prudent ratio of 9-to-1 of nurse practitioners. physician assistants or nurse-midwives for each collaborating or supervising physician while also preserving that physician’s autonomy and authority regarding patient care decisions within each collaborative or supervisory arrangement. The bill did not pass, but will return.

If no one was on call . . . optometrists could have begun performing eye surgeries using scalpels and lasers as well as eye injections. SB66 would have allowed optometrists, who do not undergo any surgical residencies anywhere in the U.S., to perform surgeries and injections on the eye and would also have given the Alabama Board of Optometry the sole power to define and regulate what is considered to be the practice of optometry, taking all authority away from the Legislature to define it. The bill was unfortunately rammed through the Senate Health Committee by its chairman, Jim McClendon, an optometrist himself (watch this video). The bill did not pass, but will return.

If no one was on call . . . a newly-created state board could have unilaterally set the scope of practice for imaging technologists and potentially increased costs to medical practices utilizing medical imaging. Among other things, SB171 provided for the licensing and regulation y of health care personnel performing radiologic imaging or radiation therapy for diagnostic or therapeutic purposes. While this is not problematic on its face, the bill could have increased costs for medical practices and dangerously expanded the scope of practice for non-physicians. While the bill did not receive a vote in committee, it is expected to return.

If no one was on call . . .podiatrists could have been granted the ability to perform surgery on the ankle and lower leg.HB198 would have allowed podiatrists who have completed as few as 2-years of podiatry residency (significantly less than either a general orthopaedist or an orthopaedic surgeon specializing in the ankle) to perform ankle surgery. The legislation failed to receive a vote in committee but will return.

Beating Back the Lawsuit Industry

Plaintiff trial lawyers are constantly seeking new opportunities to sue doctors. Alabama’s medical liability laws have long been recognized for ensuring a stable legal climate and fostering fairness in the courtroom. Yet, year after year, personal injury lawyers seek to undo those laws and allow more frivolous lawsuits to be filed against physicians.

If no one was on call . . .physicians could have been held liable for emergency medical treatment decisions of individuals believed to be a threat to themselves or others. Instead, physicians were protected in a revised version of the legislation, which aimed to create a process for immediate treatment of individuals believed to need mental health care. The bill did not pass but will return.

If no one was on call . . .physicians participating in a pilot project “needle exchange” program could have been held liable for helping program enrollees. Instead, revisions allowed physicians referring patients to the program and being referred patients from the program to be protected if following certain rules.

If no one was on call . . .athletic trainers and possibly other health professionals could have lost existing legal protections they currently enjoy under one proposed change to the athletic training legislation. Instead, an amendment to the legislation allows athletic trainers and other health professionals to maintain the same level of liability protection they have at present.

If no one was on call . . .physicians could have been held liable for the health of patients under their care who chose to use cannabis for medicinal use in the proposed medical cannabis bill. Instead, an amendment was adopted removing this language. The bill did not pass but will return.

If no one was on call . . .physicians could have been held liable for school system employees’ decisions regarding following portable DNR orders for minor students. Instead, an agreement was reached to ensure physicians cannot be held liable for the actions of those not under their supervision or authority in carrying out DNR orders. The bill did not pass but will return.

If no one was on call . . .physicians could have been held liable for the actions of school system employees if the physician helped create a “seizure action plan” for a minor child with a seizure disorder. Instead, physicians were protected for helping create such plans of action for school employees to follow for children with seizure disorders. The bill did not pass but will return.

Other Legislation of Interest

Medical Cannabis. . . This much-discussed legislation, (SB165) sponsored by Sen. Tim Melson (R-Florence), an anesthesiologist, would provide for the regulation by the state, from “seed to sale”, of cannabis for medicinal use. After surveying its members, the Association found Alabama physicians believe if cannabis for medicinal use is legalized, then the growth, cultivation and sale of cannabis should be highly regulated by the state, and any physician involvement should be regulated not by some new state agency, but by the Board of Medical Examiners. As a direct result of Alabama physicians’ survey responses, the Association worked to bring the legislation in line with the areas of broad medical agreement on the topic. The bill passed the Senate but stalled when it reached the House. It will return.

If no one was on call . . .various bills establishing standards of care in the law for physicians to follow or be penalized could have become law. Instead, no such legislation passed, but the Association works on bills of this type every time the legislature comes into session.

If no one was on call . . .physicians could have been charged with manslaughter or murder if a patient experiences a deadly overdose that involved a drug the physician prescribed. The legislation, intended to target drug dealers, was revised to protect physicians.

The Office for Civil Rights (“OCR”), the entity responsible for HIPAA compliance and enforcement, has issued a series of guidance documents regarding the interplay of HIPAA and the COVID-19 pandemic. The most recent guidance serves as a reminder to health care providers to follow the requirements of HIPAA when speaking with the media or allowing filming within the office or facility. This has even greater importance due to the increased amount of media attention on healthcare providers and the facilities treating COVID-19 patients.

The recent guidance reminds health care providers that the HIPAA Privacy Rule is not altered during the COVID-19 public health emergency. HIPAA does not permit a health care provider to give media and film crews access to facilities where patients’ protected health information (“PHI”) will be accessible without the patients’ prior authorization. Even during the current COVID-19 public health emergency, health care providers are still required to obtain a valid HIPAA authorization from each patient whose PHI will be accessible to the media. Consistent with past guidance, OCR reminds providers that masking or obscuring patients’ faces or identifying information before broadcasting a recording of a patient is not sufficient. According to the guidance, by way of an example, “a covered hospital may not allow media personnel access to the emergency department where patients are receiving treatment for COVID-19, without first obtaining each patient’s authorization for such filming.”

We have seen at least two (2) previous OCR investigations regarding inappropriate disclosure of PHI to film crews (in 2016 and 2018), both of which were resolved with corrective action plans and monetary settlements. I would not be surprised if we see additional future OCR enforcement actions in this regard in light of the increased media coverage surrounding COVID-19.

Today, Gov. Ivey issued an executive order protecting physicians, their staff, and their practices from lawsuits related to COVID-19. The governor’s order, the eighth such supplemental emergency order issued by her administration since the pandemic began, provides a “safe harbor” for services affected by COVID-19 or Alabama’s response to the pandemic and from other COVID-19 related claims.

“As one of many Alabamians on the front lines of this pandemic, I thank Gov. Ivey for working with the Medical Association to provide this much-needed liability protection for these unprecedented circumstances affecting care provisions that are far beyond any of our control,” Medical Association President John Meigs, Jr., M.D., said.

The order provides immunity for treatment that resulted from, was negatively affected by or was done in response to the COVID-19 pandemic or the State’s response to the pandemic unless proven by clear and convincing evidence that a health professional acted with wanton, reckless, willful, or intentional misconduct – a standard significantly higher than simple negligence. Importantly, the liability protections in today’s order apply retroactively to March 13, 2020, and will remain in place until the COVID-19 public health emergency is terminated.

Protecting physicians, their staff, and medical practices from COVID-19 lawsuits has been a priority of the Medical Association since Alabama entered a state of emergency in mid-March. In addition to the governor’s office, the Association has worked with multiple other organizations on today’s order and appreciates the expertise of the Birmingham law firm of Starnes, Davis and Florie during those negotiations. Click the button below to view a summary of the proclamation.

Alabama State Senator Arthur Orr (R-Decatur) is preparing to file a bill today to provide liability protection to physicians, health facilities and businesses from claims arising from COVID-19 and the state’s response to the pandemic.

“These are unprecedented times and the Legislature must take swift action to protect physicians and businesses from COVID-19 frivolous lawsuits,” Sen. Orr said. “We cannot wait to pass this legislation, as every day that goes by without these protections in place could mean these entities have unknown liability exposure for situations and dynamics far beyond their control.”

Medical Association President John Meigs, M.D., thanked Sen. Orr for his willingness to bring forward the legislation.

“Practices of every specialty of medicine have been affected by this pandemic, from both the care-provision aspects but also the economic and business side. The association appreciates Senator Orr’s leadership and willingness to bring this critical legislation forward,” Dr. Meigs said.

The bill has widespread support among the health care and business communities. The Legislature may meet as few as five legislative days this week but has as many as 14 at its disposal. Most of the focus this week will be on local bills and the two state budgets, but the Medical Association is also encouraging legislators to take up Sen. Orr’s bill as a top priority.

Starnes, Davis, Florie, LLP has drafted a summary with some guidance on documentation for physicians concerning some protection in response to potential liability issues facing physicians during the COVID-19 declared emergency. Governor Ivey’s March 13, 2020 Proclamation declared a state public health emergency. The Proclamation grants certain immunity from lawsuits if a provider in a covered “health care facility” is practicing pursuant to an “alternative standard of care” plan. The “alternative standard of care” must be set forth in the “health care facility’s” emergency operation plan, and the specific language or “standards of care” may differ from facility to facility. Starnes suggests documenting the circumstances surrounding each patient and the reasons for clinical decisions. [LINK to previous article]. Personnel and a facility are entitled to limited immunity when practicing consistent with those methods outlined in the alternative standard of care. Physicians should look to the hospital for the specific protective language.

The PREP Act provides limited immunity for the administration or use of covered countermeasures to treat, diagnose, cure, prevent, or mitigate COVID-19. The PREP Act covers providers for the administration or use of any antiviral, any other drug, any biologic, any diagnostic, any other device, or any vaccine used in the treatment of a COVID-19 patient.

This information is not intended to provide legal advice, and no legal or business decision should be based on its content. No representation is made that the quality of legal services to be performed is greater than the quality of legal services performed by other lawyers. Read full disclaimer.

The changes made to
the requirements for telehealth services since the start of the COVID-19
pandemic have been swift and substantial. For the first several weeks, it seems
changes were made almost daily. As time
has passed, the changes to telehealth have stabilized enough that a summary of
the current telehealth issues is possible. However, changes may still be
forthcoming so the following is a summary of the significant topics related to
providing telehealth services as of the date of this article. Physicians should
continue to monitor announcements related to telehealth requirements as changes
will surely continue to evolve.

Medicare – On
March 30, 2020, the Centers for Medicare & Medicaid Services (CMS)
announced additional temporary expansion of telehealth services to Medicare
beneficiaries. CMS’s announcement of this new reimbursement flexibility builds
on its prior expansion of telehealth services to address the COVID-19 pandemic.
Prior to the March 30, 2020 announcement, CMS announced the following: (1) the
patient location requirement was being waived to allow the patient to be in
their home or other location; (2) the audio-video link can be something as
simple as Skype, FaceTime or Facebook Messenger video calls. However, the
audio-video link has to be a real-time audio and a one-to-one video connection,
and cannot be public-facing; (3) the patient cost share can be waived at the
providers’ discretion; and (4) CMS stated it will not audit to verify that
there is an established patient relationship.

CMS announced in its
March 30, 2020 announcement that it is now also allowing Medicare beneficiaries
to receive care via telehealth by: (1) adding more than 80 services to the list
of services payable under the Medicare Physician Fee Schedule when furnished
via telehealth, including emergency department visits, initial nursing facility
and discharge visits, critical care services, home visits for new and
established patients, and physical and operational therapy services; (2)
allowing clinicians to provide Virtual Check-In services to new patients
in the same manner as they previously could provide only to established
patients; (3) allowing licensed clinical social workers, clinical
psychologists, physical therapists, occupational therapists, and speech
language pathologists to provide e-visits; (4) allowing clinicians to provide
certain services by audio phone only to their patients; (5) allowing
clinicians to provide Remote Patient Monitoring, for acute or chronic
conditions, to both new and established patients; (6) removing certain
frequency limitations on Medicare telehealth; (7) expanding the use of
telehealth to certain home health and hospice services; and (8) expanding the
definition of “homebound” so that when a physician determines that a Medicare
beneficiary should not leave the home due to suspected or confirmed COVID-19,
the patient can qualify for the Medicare Home Health benefit.

Medicare
Miscellaneous Issues – Patient consent may be obtained annually and
obtained by ancillary staff. Direct
Supervision of services, such as incident-to services, normally require that
the supervising/billing physician be in the office suite and immediately
available. However, for the duration of the PHE, direct supervision can be
provided by real-time interactive audiovisual technology.

CMS
is allowing payment for certain codes related to telehealth services because as
an example, CMS recognizes that some problems can be handled over the phone
without a face-to-face, but may require more than the 5-10 minutes. The codes
for established patients for physician or other qualified professionals
(nurse practitioners or physician assistants) include 99441 (requires 5-10
minutes of medical discussion), 99442 requires 11-20 minutes of medical
discussion), 99443 (requires 21-30 minutes of medical discussion).
Practitioners should report the E/M code that best describes the nature of the
care they are providing. Previous guidance was to use POS 02 that will cause
payment to be made at the lower facility rate. Alternatively, providers can
choose to use the POS code that most accurately reflects where the service is
performed and append modifier 95. This will cause payment to be made at the
higher non-facility rate.

Alabama
Medicaid – Medicaid normally requires separate credentialing for providers
performing telehealth; however, that restriction has been waived for the time
period for dates of service from 3/16/2020 – 4/16/2020. Medical providers may
bill established patient evaluation and management codes 99211, 99212 and 99213
for telephone consultations. Psychologists and behavioral health
professionals should bill 90832, 90834, 90837, 90846, 90847 and H2011. Verbal
consent must be obtained and documented in the medical record. These visits
will count against the patient’s office visit limit of 14 visits per year.

Blue
Cross and Blue Shield of Alabama – is allowing providers to bill for
telephone call treatment of existing patients under the established patient
office visit codes for dates of service from 3/16/2020 – 4/16/2020. They are
allowing codes up to 99213 with place of service code 02 for telehealth. No
modifier is required. The physician should be the one speaking with the patient
— not the office staff.

HIPAA – Over the past several weeks, the Office for
Civil Rights (“OCR”) has issued several notices regarding HIPAA in
light of the current COVID-19 pandemic. The OCR issued a Notification of
Enforcement Discretion for Telehealth Remote Communications during the COVID-19
Nationwide Public Health Emergency. OCR stated that it would relax its
enforcement actions with regard to compliance with certain aspects of HIPAA
(and not enforce penalties) in order to allow providers to better treat their
patients via telehealth. A health care provider that wants to use audio or
video communication technology to provide telehealth to patients during the
public health emergency can use any non-public facing remote audio or video
communication product that is available to communicate with patients. Health
care providers may use applications that allow for video chats, including Apple
FaceTime, Facebook Messenger video chat, Google Hangouts video, or Skype, to
provide telehealth without risk that OCR might seek to impose a penalty for
noncompliance with the HIPAA Rules. However, communication applications that
are public facing should not be used. OCR further stated that it would not
impose penalties against health care providers for the lack of a Business
Associate Agreement with video communication vendors. The above applies to
telehealth provided for any reason, regardless of whether the telehealth
service is related to the diagnosis and treatment of health conditions related
to COVID-19. The OCR also issued additional guidance in the form of frequently
asked questions (FAQs) which are available at https://www.hhs.gov/sites/default/files/telehealth-faqs-508.pdf.

State Licensure – Most states have greatly relaxed
or streamlined their licensing requirements and application process to make it
easier for physicians to provide telehealth services across state lines.
However, the application process and requirements for each state differ so it
is extremely important for physicians to check with each state. For example,
the state of Tennessee requires the practitioner to complete and submit an
application, which can be found at: https://www.tn.gov/content/dam/tn/health/documents/cedep/novel-coronavirus/Boards-Executive-Order-Form.pdf.
The determination is made on a case by case basis. It appears most applications
are being approved by the Tennessee Department of Health because as of the end
of March 2020 the Department had received 61 applications and approved 59
applications, denied one, and one was under review. The State of Florida, for
purposes of preparing for, responding to, and mitigating any effect of
COVID-19, permits health care professionals not licensed in Florida to provide
health care services to a patient located in Florida using telehealth, for a
period not to exceed 30 days unless extended by order of the State Surgeon
General. The exemption applies only to out of state health care professionals
holding a valid, clear, and unrestricted license in another state or territory
in the United States who are not currently under investigation or prosecution
in any disciplinary proceeding in any of the states in which they hold a
license.

While the telehealth waivers and notifications have
slowed down in recent days, it is still very important for physicians to keep
updated on the various requirements from state licensing authorities and
payors.

Jim Hoover
practices with Burr & Forman LLP and works exclusively within the firms
Health Care Industry Group and primarily handles healthcare litigation and
compliance matters.

Over the past month, as more nationwide “Shelter at Home” orders have been issued and more companies have transitioned to telework, the need for online meetings and webinars has skyrocketed. To accommodate this new way of doing business, many have turned to a platform called Zoom. The problem? No one bothered to read the fine print.

For those in the healthcare field, privacy is paramount. Yet, by using Zoom, users are seceding any and all content displayed or vocalized to the company. In Zoom’s own privacy statement, some of the “Customer Content” it collects includes “information you or others upload, provide, or create while using Zoom.”[i] Additionally, Zoom also collects personal information like your name, physical address, email address, phone number, job title, employer.[ii] And, even if you don’t make an account with Zoom, it will collect and keep data on what type of device you are using, and your IP address.[iii]

Now,
while Zoom has recently updated its privacy policy and is taking steps to make
the platform more secure, there are issues beyond the data mining mentioned
above. On
Monday, for instance, the Boston office of the Federal
Bureau of Investigation issued a warning[iv] saying that it had
received multiple reports from Massachusetts schools about trolls hijacking
Zoom meetings with displays of pornography,
white supremacist imagery and threatening language — malicious attacks known as “zoombombing.”[v]

So, what’s the solution?
Below are a few good alternative platforms to use instead Zoom:

The world’s memory of this virus will be different when lawsuits are filed two years from now and juries try the cases two to three years after that. The acuteness of the issues, the confusion, the limited resources and the changing daily directives will not be remembered in any meaningful detail. Accordingly, the Risk Management dogma that has always emphasized charting is more important now than usual. If the standard of care is judged as care “under the same or similar circumstances”, and those circumstances are “delivering care in a COVID-19 pandemic”, how will we show those circumstances in a 2025 jury trial? We recommend vigilant documentation.

In consideration of Alabama’s sample ventilator allocation guidance, and exemplary language from other states, Starnes, Davis, Florie, LLP. recommends the below language be charted in circumstances where a resource may be diverted away from a patient who could be in need. The sample language specifically applies to decisions in triaging a patient and any initial treatment decisions regarding a specific (limited) resource.

Sample Language:

In making a clinical judgment regarding the allocation of [resource] during the [COVID-19 pandemic / public health emergency], I have assessed the patient’s history, symptoms, and condition and considered the limited availability of resources and clinical factors associated with the allocation of limited resources. My clinical judgment, under the totality of the circumstances, is that [clinical decision] is appropriate for this patient as an alternative medical intervention.

We also recommend against language or specific explanations to patients as follows:

· Language / an explanation to a patient or a patient’s family explicitly referencing financial issues or considerations.

· Language / an explanation to a patient or patient’s family focusing the considerations on the resource itself as opposed to the specific patient.

· Language / an explanation to a patient or patient’s family specifically documenting the condition of other patients or the specific condition of other patients receiving resources.

· Language / an explanation to a patient or a patient’s family specifically quantifying any patient’s likelihood of successful treatment – that being the patient receiving the resource and the patient not receiving the resource.

· Language / an explanation to a patient or a patient’s family specifically comparing patients or outcomes.

· Language / an explanation to a patient or a patient’s family specifically referencing medical ethics. Medical ethics underpins all clinical decisions and does not need to be specifically included in the chart.

This information is not intended to provide legal advice, and no legal or business decision should be based on its content. No representation is made that the quality of legal services to be performed is greater than the quality of legal services performed by other lawyers. Read full disclaimer.

The Office of Civil Rights (“OCR”), the government agency tasked with HIPAA compliance and enforcement, recently announced a change impacting a patient’s right to access his/her medical records—a change which is, given OCR’s history, surprisingly favorable to providers.

One of the long-standing premises of HIPAA has been a patient’s right to access his/her medical records. For years, the HIPAA regulations have limited the fees that providers can charge patients when they request a copy of their medical records to a reasonable, cost-based fee (regardless of the permitted state law fees). HITECH expanded this right a few years ago by allowing patients to exercise their right to access medical records, but designate a third-party to whom the records should be sent (e.g., the patient’s attorney). These requests from patients to send their records to a designated third-party are oftentimes referred to in the industry as “HITECH” requests.

Subsequent OCR guidance stated that the historical limitation on fees that applied when a patient exercised his/her right to access medical records would also apply to the situation where a patient requested that his/her records be sent to a designated third-party pursuant to a “HITECH” request. As a result, providers were limited in what they could charge third-parties, such as attorneys, seeking access to medical records by way of a “HITECH” request from a patient, as opposed to by way of a HIPAA authorization.

However, based on a recent court order, such limitation on fees no longer applies to “HITECH” requests. As a result of the recent court decision, OCR has clarified that “the fee limitation set forth at 45 C.F.R. § 164.524(c)(4) will apply only to an individual’s request for access to their own records, and does not apply to an individual’s request to transmit records to a third party.” Thus, as a result of this recent court decision, providers, and their business associates, are no longer bound by the HIPAA-imposed limitation on fees when a patient requests that a copy of his/her medical records be sent to a designated third party (e.g., attorney). For these “HITECH” requests, providers can now charge fees acceptable under state law, without applying the HIPAA fee limitations. These state law fees are oftentimes higher than the HIPAA fees. Further, the court decision clarified that such “HITECH” requests are limited to requests for an electronic health record with respect to PHI maintained in an electronic format.

OCR has been clear that the HIPAA limitation on fees, however, will continue to apply to patient requests to access their own medical records when the records are delivered directly to the patient. Nonetheless, this shift in guidance is favorable to providers and much welcomed by the healthcare industry.

The Protecting Access to Medicare Act (PAMA) was passed in 2014. PAMA required the Centers for Medicare and Medicaid Services (CMS) to establish a program that promotes “Appropriate Use Criteria” (AUC) for advanced diagnostic imaging. AUC’s are evidence-based criteria that assist professionals who order and furnish certain imaging services to make the most appropriate treatment decisions for specific clinical conditions. Once the AUC program is fully implemented (2021), payment will only be made for an advanced diagnostic imaging service if the Medicare claim indicates that the ordering professional consulted with a qualified Clinical Decision Support Mechanism (CDSM) about whether the ordered service meets an applicable AUC. A CDSM is an interactive electronic tool for use by clinicians that communicates AUC information and assists in making appropriate treatment decisions during a patient’s workup. An ordering professional is a physician or other licensed professional who orders an imaging service. The settings covered include hospital outpatient departments (which includes the hospital’s ER), ambulatory surgery centers, physicians’ offices and IDTF’s.

Advanced diagnostic imaging services include
MRI’s, CT scans, PET scans and nuclear medicine. The CDSM must be reported on
claims for payment using G-codes, modifiers and, eventually, the ordering
physician’s NPI. For the period July 1, 2019, through December 31, 2019, only
voluntary reporting was required. Beginning January 1, 2020, an
educational and operations testing period will be implemented, which is
expected to run through December 31, 2020. For now, CMS will still pay a claim,
whether or not the claim correctly includes AUC information. Eventually, CMS
must develop outlier criteria (which will require some ordering professionals to
obtain prior authorizations) and will not pay those claims that do not have AUC
information, unless a specific exception is met. The exceptions include emergency
services provided to individuals with emergency medical conditions (EMTALA
definition), inpatient care where payment is made under Part A Medicare, or
significant hardships, which includes insufficient internet access and EHR or
CDSM vendor issues.

Qualified CDSM’s
(only national professional medical specialty societies or other organizations
of providers who predominantly provide direct patient care may develop CDSM’s)
must be approved by CMS and must meet other criteria, such as providing a
certification or other documentation at the time of the order that a qualified
CDSM was consulted, and whether or not the service ordered met the requirements
of the specific referenced AUC. The regulations also list certain “priority
clinical areas” that will be monitored to identify outlier ordering
professionals as follows: coronary artery disease (suspected or
diagnosed), suspected pulmonary embolisms, headache (traumatic and
non-traumatic), hip pain, low back pain, shoulder pain (including suspected
rotator cuff injury), cancer of the lung (primary or metastasis, and suspected
or diagnosed), and cervical and back pain. Ordering physicians and settings for
these imaging services should begin the process of including AUC’s on Medicare
claims in January 2020.